Who else makes this device?

Name: Signature
Brand: Signature

Signature · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer → Orthopedic

21manufacturers in China registered for this device type

49catalogue numbers in this listing

13510(k) clearances naming this product code

Who Else Makes It

Concentrated in Jiangsu (10), Shanghai (4), Beijing (3). 13 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code JWH
Manufacturer	City	Province	Registered as	Device types
MicroPort Orthopedics Global Supply Center Limited	Shanghai	Shanghai	Contract manufacturer	82
Zhejiang Biomet Medical Products Co., Ltd.	Jinhua	Zhejiang	Contract manufacturer	74
Paragon Medical Device (Changzhou) Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	53
Canwell Medical Co., Ltd.	Jinhua	Zhejiang	Contract manufacturer	42
Suzhou Elite Precision Machinery Co., Ltd.	Kunshan	Jiangsu	Contract manufacturer	35
Guangzhou Aquila Precise Tools Limited	Guangzhou	Guangdong	Contract manufacturer	28
B-ONE Medical (Suzhou) Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	23
LX Precision Shanghai Co Ltd	Shanghai	Shanghai	Contract manufacturer	19
Stryker (Suzhou) Medical Technology Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	19
Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	10
b-ONE Medical (Beijing) Co., Ltd.	Beijing	Beijing	Contract manufacturer	7
Changzhou Wastonortho Medical Appliance Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	5

Showing 12 of 21. All 21 manufacturers in China registered for Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Record

Regulatory record for Signature
Listed by	Materialise NV, Belgium
FDA product code	JWH
Device type	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class	Class 2
Regulation	21 CFR 888.3560
510(k)	K102795
Record published	2016-09-24
Record revised	2024-08-20 (version 6)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Moist Heat or Steam Sterilization, Hydrogen Peroxide
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date
Distribution end date	2019-03-01

Catalogue Numbers

Catalogue numbers for Signature
Catalogue number	Size	Status
42-422560		Withdrawn
42-422761		Withdrawn
42-422556		Withdrawn
42-422760		Withdrawn
42-422553		Withdrawn
42-422566		Withdrawn
42-422567		Withdrawn
42-422772		Withdrawn
42-411563		Withdrawn
42-422557		Withdrawn
42-422763		Withdrawn
42-422565		Withdrawn
42-411560		Withdrawn
42-422578		Withdrawn
42-422552		Withdrawn
42-422551		Withdrawn
42-422575		Withdrawn
42-411570		Withdrawn
42-422770		Withdrawn
42-422568		Withdrawn
42-422753		Withdrawn
42-411574		Withdrawn
42-411562		Withdrawn
42-422410		Withdrawn
42-422563		Withdrawn
42-422555		Withdrawn
Signature Planner		Withdrawn
42-411572		Withdrawn
42-422751		Withdrawn
42-422571		Withdrawn
42-422573		Withdrawn
42-433410		Withdrawn
42-411564		Withdrawn
42-422577		Withdrawn
42-422577		Withdrawn
42-422762		Withdrawn
42-422561		Withdrawn
42-422771		Withdrawn
42-422562		Withdrawn
42-411573		Withdrawn
42-422576		Withdrawn
42-422572		Withdrawn
42-422752		Withdrawn
42-411561		Withdrawn
42-422750		Withdrawn
42-422773		Withdrawn
42-422558		Withdrawn
42-422550		Withdrawn
42-411571		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Prophecy®	Microport Orthopedics Inc.	4,423
Exult Knee Replacement System	Corentec Co., Ltd.	1,770
Freedom	Maxx Orthopedics Inc.	1,693
Legion	Smith & Nephew, Inc.	1,534
MyKnee	Medacta International SA	1,466
Journey	Smith & Nephew, Inc.	1,339
Persona®	Zimmer, Inc.	1,254
DJO Surgical	Encore Medical, L.P.	1,131
U2 Total Knee System	United Orthopedic Corp.	1,078
CKS Plus	Shalby Advanced Technologies, Inc.	1,024
Lospa Modular Knee System	Corentec Co., Ltd.	1,020
Natural-Knee®	Zimmer, Inc.	980

Showing 12 of 1,175. All products under Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K253793	2026-01-06
K251554	2025-07-14
K221337	2022-07-05
K173445	2018-02-02
K162273	2016-11-07
K150928	2015-08-10
K140027	2014-05-22
K133162	2014-02-25
K121640	2012-12-05
K113829	2012-04-02
K111492	2011-10-13
K102795	2011-02-02
K091263	2009-11-19

Recalls Naming This Product

4 recalls name this product by its own identifiers, the 510(k) it is cleared under.

Recalls naming the identifiers of Signature
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Materialise USA, LLC.	510(k) number	2016-05-03	Class II	Process control	A patient specific case of Signature Personalized Patient Care System Knee Guides included a femur guide which does not match the patient associated with the case. If the issue is not identified prior to surgery, the personalized patient sp	1	2016-06-28
Materialise N.V.	510(k) number	2015-02-04	Class II	Employee error	Images belonging to a different patient were used for the production of the patient specific surgical guide. The incorrect guide may cause a delay in surgery to accommodate the preparation and use of traditional instrumentation.	1 unit	2015-10-30
Materialise USA, LLC.	510(k) number	2013-11-26	Class II	Nonconforming Material/Component	Shipped femur guide contained a non-conformance which could possibly impact fit of the drill insert.	1	2014-01-14
Biomet, Inc.	510(k) number	2011-08-04	Not classified	Labeling mix-ups	Biomet has initiated this action following investigation that identified two (2) specific lots of part number 42-422561 were incorrectly labeled. One (1) unit (lot 025640) was received back from distributor’s office as a product complaint.	2 units	2012-09-06

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Signature